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Elizabeth Orr

Washington, DC
Elizabeth Orr focuses on legal affairs affecting the medical device industry. Before joining Informa in September 2015, she spent three years spent reporting on all things device-related at FDANews. She remains fascinated by the ever-changing master class on technology, government regulations, advances in health care and more that is covering the device industry. Elizabeth’s past employers include DecisionHealth (formerly UCG); the Society of Interventional Radiology; and the Washington Examiner.  A graduate of the College of Journalism at the University of Maryland College Park, she lives in Arlington, Va., with her husband and children.

Latest From Elizabeth Orr

Edwards, Abbott Settle Mitral Repair Patent Cases

Edwards Lifesciences is paying Abbott Laboratories to settle disputes over patents on transcatheter mitral and tricuspid repair products.

Intellectual Property Legal Issues

FDA Focuses On Animal Testing, Trial Endpoints In BPH Device Draft Guidance

Draft guidance from the US FDA updates the agency’s recommendations around research to support new devices for the treatment of prostate enlargement.

Gynecology & Urology Guidance Documents

COVID-19: PPP Loan Program Awarded Up To $1.6Bn To Medtech Firms

Medical device companies – including Sientra, Endologix and Invacare – won loans from the US government’s Paycheck Protection Program, intended to protect jobs during the coronavirus pandemic. In total, nearly 1,400 device makers collected as much as $1.6bn, according to a Medtech Insight analysis of PPP data.

Policy Companies

Warning Letter Close-Outs – June 2020

The US FDA released five device-related close-out letters in June. An additional close-out letter, dated February 2017, was published for the first time recently due to an agency oversight.

Device Warning Letters FDA

FDA Clears CDC Diagnostic For COVID-19 And Influenza

The US FDA has authorized marketing of a combination diagnostic that can detect either COVID-19 or influenza. The agency hopes to encourage development of additional similar tests before the fall flu season.

Diagnostics In Vitro Diagnostics

J&J Wins Injunction Against Alleged Counterfeit Product Distributor

Medical supplies distributor eSutures is facing a federal injunction over allegations the vendor sold counterfeit surgical supplies purportedly made by Johnson & Johnson unit Ethicon.

Legal Issues Medical Device
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